Associate Director, Global Pharmacovigilance Quality Management

Sarepta Therapeutics, Inc.; Cambridge (MA); Hybrid; USD 156,000 - 195,000; Full time

Job summary

An established industry player in genetic medicine is seeking a dedicated professional to enhance pharmacovigilance processes. This role offers the chance to make a significant impact in the field of drug safety while collaborating with various departments. You will be responsible for strategic planning, compliance, and continuous improvement initiatives that ensure the highest quality standards. Join a team that values integrity, kindness, and a commitment to patient care. If you are a solution-oriented thinker who thrives in a dynamic environment, this opportunity is perfect for you.

Benefits

Comprehensive benefits package

Support for Caregivers

Financial Wellness resources

Physical and Emotional Wellness programs

Qualifications

• 8-10 years' experience in Quality Management or related fields.
• Strong systems-thinking and strategic planning skills required.

Responsibilities

• Facilitate PV quality planning and improve PV processes.
• Collaborate across departments to enhance Sarepta processes.

Skills

Systems Thinking

Problem-Solving

Decision-Making

Quality Management

Communication Skills

Project Management

Continuous Improvement

Education

Advanced degree in Sciences

Advanced degree in Engineering

Advanced degree in Nursing

Advanced degree in Healthcare Administration

Tools

MS Office

MS Visio

Job description

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

1. Physical and Emotional Wellness
2. Financial Wellness
3. Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role
This position facilitates quality planning, regulatory compliance, and continuous improvement of Sarepta's pharmacovigilance (PV) processes and systems across Sarepta's investigational and marketed products and partner/vendor collaborations. This position requires a learning agile and experienced professional with strong systems-thinking, problem-solving and decision-making skills. The incumbent will join the Global Pharmacovigilance and Risk Management (GPVRM) department, reporting directly to the Head of Global Pharmacovigilance Quality Management.

The Opportunity to Make a Difference

• Facilitate strategic PV quality planning and identify, analyze, and implement opportunities for continuously improving Sarepta PV processes and systems.
• Collaborate with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, etc. in establishing and continuously improving Sarepta processes.
• Manage cross-functional projects utilizing industry-standard project management methods.
• Monitor GPV and vendor PV compliance against applicable plans, standard operating procedures, contracts, regulations and guidelines.
• Establish PV operating policies and procedures aligning with governing regulations, departments, and partnering functions. (Includes mapping of new and existing PV processes using MS Visio.)
• Lead the implementation and maintenance of a comprehensive PV training program. Develop and deliver training curricula and content to internal and external Sarepta stakeholders.
• Implement and oversee PV Agreements for vendors, distributors, and license partners.
• Monitor Key Performance Indicators and metrics. Coordinate collation of data for management reports and score cards.
• Lead the PV deviation/CAPA program and manage deviations and CAPAs related to PV, inclusive of internal and vendor origin.
• Maintain a PV self-inspection program ensuring constant inspection readiness.
• Manage the audit/inspection backroom and represent PV in audits and inspections, including direct interactions with auditors and inspectors.
• Support patient access and market expansion through implementation and maintenance of local and global in-country safety reporting compliance.
• Consult, review, and approve PV and stakeholder procedures, documents, records, contracts, Pharmacovigilance and Safety Data Exchange Agreements, program and study plans, and other material with PV impact.

More about You

• Advanced degree in Sciences, Engineering, Nursing, or Healthcare Administration
• Minimum 8 - 10 years' experience in Quality Management or related professional experience
• Demonstrated systems-thinking, strategic planning, and quality management skills with attention to detail
• Proven ability to build relationships and influence across disciplines and all levels
• Experience leading continuous improvement initiatives
• Excellent written and verbal communication skills
• Proficient with MS Office and Visio
• Experience with QMS, audit and inspection management, document and training management, CAPA and project management
• Working knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA, and ICH guidelines preferred
• Exhibits attributes congruent with Sarepta Behaviors: Patient Mission, Scientific Rigor, Simplicity, Bias to Action, One Sarepta, and Trust
• Global experience is preferred
• Occasional travel may be required

What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Remote
#LI-PM1
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.